The MDR and the IVDR Regulations provide for transitional periods during which devices compliant with the previous Directives may still be placed on the EU market:
- Council Directive 90/385/EEC on active implantable medical devices
- Council Directive 93/42/EEC concerning medical devices
- Directive 98/79/EC on in vitro diagnostic medical devices
TIMELINE FOR THE TRANSITION FROM THE DIRECTIVES TO THE MDR
18/12/2024 © European Union, [2024] (ISBN: 978-92-79-90431-8 DOI: 10.2873/89881)
On 15 March 2023, REGULATION (EU) 2023/607 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was adopted at EU level. It extends, subject to the fulfilment of certain conditions, the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC, removes the disposal date for medical devices and in vitro diagnostic medical devices, and lays down obligations and responsibilities of notified bodies with regard to vigilance control of medical devices. More information on the changes is available at the following link.
TIMELINE FOR THE TRANSITION FROM THE DIRECTIVE TO THE IVDR
On 13 June 2024, Regulation (EU) 2024/1860 amending the MDR and the IVDR Regulations was adopted at EU level with regard to the progressive introduction of the European Database on Medical Devices (EUDAMED), the obligation to provide notification in the event of interruption or cessation of supply, the deferred application of the obligations for in-house devices and the transitional provisions for certain in vitro diagnostic medical devices. More information on the changes is available at the following link.
The obligations of the MDR and the IVDR Regulations concerning post-market surveillance, market surveillance, vigilance and the registration of economic operators and devices apply both to devices compliant with the MDR and the IVDR Regulations and to devices compliant with the Directives that remain on the market in accordance with the transitional provisions of the MDR and the IVDR Regulations.
